The U.S. Food and Drug Administration (FDA) has issued a news release warning consumers about a counterfeit and potentially harmful version of the over-the-counter weight loss drug Alli. The warning is concerning Alli 60 mg capsules in a 120-count refill kit.

According to preliminary laboratory tests conducted by GlaxoSmithKline, the manufacturer of Alli, the counterfeit version does not contain orlistat, the active ingredient of Alli. Rather, the counterfeit product contains sibutramine, a controlled substance that can interact with other medications and should not be used in certain patients or without the advice of a health care professional.

Consumers first began reporting suspected counterfeit Alli products in early December 2009. GlaxoSmithKline has determined that the counterfeit product has been sold over the internet. At the present time, there is no evidence that any counterfeit Alli product has been sold through retail stores or other channels.

Although the counterfeit Alli product looks similar to the real thing, there are some differences in the packaging, as well as in the pill itself. For example, the outer cardboard packaging of the counterfeit Alli product is missing a ‘Lot’ code and is printed with an expiration date that includes the month, day, and year. In addition, unlike the counterfeit Alli product, the authentic product seal is printed with the words “SEALED for YOUR PROTECTION.” Authentic Alli capsules contain small white pellets, while the counterfeit versions are larger capsules with a white powder.

Consumers who believe they have received counterfeit Alli are encourage to contact the FDA’s Office of Criminal Investigations by calling 800-551-3989 or visiting www.fda.gov/OCI.

Source:

U.S. Food and Drug Administration news release 18 January 2010.